Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors
Primary Purpose
Traumatic Stress Disorder, Cancer
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Stress Disorder focused on measuring narrative exposure therapy
Eligibility Criteria
Inclusion Criteria:
- Adults (18 and over)
- Diagnosed with cancer in adulthood
- Able to provide informed consent
- Able to communicate verbally and speak English
- Not in active treatment (at any stage post-treatment)
- Suffer from symptoms of traumatic stress caused or triggered by the cancer experience. A diagnosis of PTSD is not required (PTSD Checklist Civilian, PCL-C cut-off score: 29 and above).
- No specific form of cancer
Exclusion Criteria:
Participants have a known diagnosis of Intellectual Disability (ID)
- Participants must not be receiving other forms of psychosocial support whilst engaging in NET
- They are substance dependent
- They are actively psychotic
Sites / Locations
- The University of Nottingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Narrative Exposure Therapy
Arm Description
This is a single case series design which focuses on assessing whether Narrative Exposure Therapy could reduce symptoms of traumatic stress in cancer survivors; no comparator will be included.
Outcomes
Primary Outcome Measures
Change in PTS symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by thePTSD Checklist - Civilian (PCL-C; Weathers et al., 1994)
The PCL-C explores items related to individuals' past stressful experiences using a 17-item self-report checklist (Weathers et al., 1994). The PCL-C has been widely used in cancer research (such as DuHamel et al., 2010; Levine et al., 2005; Lleras de Frutos et al., 2020; Ochoa-Arnedo et al., 2020) and was assessed as a screening instrument by Andrykowski and colleagues in their study with breast cancer survivors in 1998. The PCL-C has shown good internal consistency (Cronbach's alpha >.75) (Wilkins et al., 2011) and good test-retest reliability with scores ranging from 0.68 and 0.92 (Hahn et al., 2015). Scores above 29 are indicative of clinical concerns; the US Department of Veterans Affairs recommends a cut-off score of 30 to 38 for diagnosis of PTSD (www.ptsd.va.gov).
Secondary Outcome Measures
Change in depression and anxiety symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed byHospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
The HADS is the most extensively studied mood scale in cancer services (as well as in other medical settings) (Mitchell et al., 2010). It is a fourteen item self-report measure of anxiety and depression that has demonstrated to be psychometrically robust showing good internal consistency (Anxiety Cronbach's alpha = .83; Depression Cronbach's alpha = .82) (Bjelland et al., 2002) and good test-retest reliability (Anxiety r = .82; Depression r = .52) (Martin & Thompson, 2002). Scores of 8 and above are indicative of clinical concerns.
Change in cancer-specific quality of life between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by the Functional Assessment of Cancer Therapy - General 7 items (FACT-G7; Yanez et al., 2013)
The FACT-G7 is a brief, cancer-specific quality-of-life measure comprising 7 items from the 27-item Functional Assessment of Cancer Therapy-General Scale (FACT-G; Cella et al., 1993) that were endorsed by cancer patients as being of highest priority. Its items comprise physical, emotional and functional domains. Total scores range between 0 and 28, and higher scores indicate better quality of life. The FACT-G7 has shown good internal consistency (Cronbach's alpha = between .72 and .80) (Mah et al., 2020) and good test-retest reliability (scores between .52 and .74) (King et al., 2020).
Full Information
NCT ID
NCT05272553
First Posted
January 6, 2022
Last Updated
May 18, 2022
Sponsor
University of Nottingham
Collaborators
National Health Service, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT05272553
Brief Title
Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors
Official Title
Investigating the Application of Narrative Exposure Therapy (NET) to Reduce Symptoms of Traumatic Stress in Cancer Patients Not in Active Treatment: a Naturalistic Single Case Study Series
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Health Service, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of the study is to evaluate the feasibility, acceptability, and potential effectiveness of NET in reducing symptoms of traumatic stress (e.g., hyperarousal, avoidance, and intrusion) in cancer patients who are not in active treatment.
Further aims include:
Can NET be effective in reducing symptoms of existential anxiety, anxiety, and depression in cancer patients who are not in active treatment?
Can NET improve the Quality of Life (QoL) of cancer patients who are not in active treatment? And are improvements in QoL associated to reduction of traumatic stress?
Can NET lead to post-traumatic growth?
Does the NET protocol need to be adapted to meet cancer patients' needs?
Detailed Description
Research has shown that cancer can lead to significant emotional and social distress. Many elements of the cancer experience can be perceived as traumatic by cancer patients, including diagnostic testing, waiting periods, prolonged and invasive treatment procedures, follow-up scans, and fear of recurrence.
Unlike single traumatic events, cancer behaves as an ongoing and chronic stressor. Emotional and social distress (including anxiety, depression, and post-traumatic stress disorders), can lead to reduced treatment compliance and less adherence to a healthy lifestyle which might compromise chances of survival.
Research has shown that due to the psychological distress experienced during diagnosis, treatment, and survivorship, cancer patients are interested in receiving psychosocial support; unfortunately, their distress is often perceived as "normal" and "manageable" by professionals. The result is that 30-40% of cancer patients are not supported.
This study aims to evaluate whether Narrative Exposure Therapy (NET) can be a feasible, acceptable, and effective intervention to reduce symptoms of traumatic stress in adult cancer patients who are not in active treatment. NET is a time-limited, structured, and evidenced-based intervention designed to reduce symptoms of traumatic stress through two main processes: fear habituation and integration of the traumas within the autobiographical memory. Six participants will be recruited with the support of Clinical Psychologists working in cancer services across Nottinghamshire and Lincolnshire, they will receive around twelve weekly interventions sessions. Changes will be explored through outcome measures administered before, during, and after the intervention and through interviews about their experience at the end.
The study is founded by The University of Nottingham. Potential benefits include providing initial evidence to address traumatic stress in cancer patients, providing an intervention which could be suitable for psycho-oncology services which might lack resources to offer long-term psychosocial support, and contributing to the evidence for the use of NET in a new group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Stress Disorder, Cancer
Keywords
narrative exposure therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Naturalistic, mixed-method, explanatory sequential measurement single case series design
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
This is a single case series design which focuses on assessing whether Narrative Exposure Therapy could reduce symptoms of traumatic stress in cancer survivors; no comparator will be included.
Intervention Type
Other
Intervention Name(s)
Narrative Exposure Therapy
Intervention Description
NET (Schauer et al., 2011) is an evidence-based, short-term, manualised treatment for trauma-spectrum disorders; it aims to reduce symptoms of traumatic stress in individuals who continue to suffer from past experiences of traumatic stressors; NET combines principles of CBT, Testimony Therapy, and Exposure Therapy.
Primary Outcome Measure Information:
Title
Change in PTS symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by thePTSD Checklist - Civilian (PCL-C; Weathers et al., 1994)
Description
The PCL-C explores items related to individuals' past stressful experiences using a 17-item self-report checklist (Weathers et al., 1994). The PCL-C has been widely used in cancer research (such as DuHamel et al., 2010; Levine et al., 2005; Lleras de Frutos et al., 2020; Ochoa-Arnedo et al., 2020) and was assessed as a screening instrument by Andrykowski and colleagues in their study with breast cancer survivors in 1998. The PCL-C has shown good internal consistency (Cronbach's alpha >.75) (Wilkins et al., 2011) and good test-retest reliability with scores ranging from 0.68 and 0.92 (Hahn et al., 2015). Scores above 29 are indicative of clinical concerns; the US Department of Veterans Affairs recommends a cut-off score of 30 to 38 for diagnosis of PTSD (www.ptsd.va.gov).
Time Frame
Throughout the study, for approximately 31 weeks
Secondary Outcome Measure Information:
Title
Change in depression and anxiety symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed byHospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
Description
The HADS is the most extensively studied mood scale in cancer services (as well as in other medical settings) (Mitchell et al., 2010). It is a fourteen item self-report measure of anxiety and depression that has demonstrated to be psychometrically robust showing good internal consistency (Anxiety Cronbach's alpha = .83; Depression Cronbach's alpha = .82) (Bjelland et al., 2002) and good test-retest reliability (Anxiety r = .82; Depression r = .52) (Martin & Thompson, 2002). Scores of 8 and above are indicative of clinical concerns.
Time Frame
Throughout the study, for approximately 31 weeks
Title
Change in cancer-specific quality of life between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by the Functional Assessment of Cancer Therapy - General 7 items (FACT-G7; Yanez et al., 2013)
Description
The FACT-G7 is a brief, cancer-specific quality-of-life measure comprising 7 items from the 27-item Functional Assessment of Cancer Therapy-General Scale (FACT-G; Cella et al., 1993) that were endorsed by cancer patients as being of highest priority. Its items comprise physical, emotional and functional domains. Total scores range between 0 and 28, and higher scores indicate better quality of life. The FACT-G7 has shown good internal consistency (Cronbach's alpha = between .72 and .80) (Mah et al., 2020) and good test-retest reliability (scores between .52 and .74) (King et al., 2020).
Time Frame
Throughout the study, for approximately 31 weeks
Other Pre-specified Outcome Measures:
Title
Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)
Description
The SUD is a self-report scale from 0 to 10 for measuring the subjective intensity of distress experienced by an individual; subjective distress refers to uncomfortable or painful emotions felt. The SUD will be completed pre and post narration of each trauma event to assess for within session habituation and then repeated for re-narration of each trauma event for between session habituation.
Time Frame
For approximately ten weeks
Title
Change in post traumatic growth between the baseline, the last NET session, and 1 month and up to three months follow up phases - as assessed by the Post-traumatic growth inventory (PTGI; Tedeschi & Calhoun, 1996)
Description
Post traumatic growth is defined as the ability of the individual to experience positive changes in the aftermath of extremely negative experiences; the positive changes usually occur in the context of the self, interpersonal relationships, and philosophy of life (Anderson & Lopez-Baez, 2017). The PTGI consists of 21 items which cover five domains: relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. The PTGI has shown good internal consistency (Cronbach's alpha = .90) and test-retest reliability (r = .71) (Tedeschi & Calhoun, 1996).
Time Frame
On week two, week 15, week 19, and week 31
Title
Change in existential anxiety symptoms between the baseline, the last NET session, and 1 month and up to three months follow up phases - as assessed by theExistential Concerns Questionnaire (ECQ; van Bruggen, 2018)
Description
Existential anxiety represents a form of anxiety that goes beyond experiencing anxiety as a consequence of a concrete threat, it is instead related to a threat to our existence as a whole (Glas, 2003); as mentioned in the background section, cancer patients often question their own individual values and the meaning of their existence. Research has demonstrated that cancer patients with higher levels of existential well-being (e.g., less fear related to disease recurrence) report better QoL and lower emotional distress (Brady et al., 1999; Edmondson et al., 2008, Visser et al., 2010). This 13-item questionnaire covers anxiety in reaction to death, guilt, and meaninglessness. The ECQ has shown good internal consistency with a Cronbach's alpha of .91 and test-retest reliability (van Bruggen, 2018).
Time Frame
On week two, week 15, week 19, and week 31
Title
Change in body awareness and autonomic reactivity between the baseline, the last NET session, and 1 month and up to 3 months follow-up phases - as assessed by the Body Perception Questionnaire Short Form - Autonomic Nervous System (Porges, 1993, 2015)
Description
The Body Perception Questionnaire (BPQ) is a self-report measure of body awareness and autonomic reactivity. For the purpose of this research project, the Autonomic Nervous System subscale was taken into consideration. The autonomic nervous system (ANS) is a set of neural pathways connecting the brain and body; these pathways send information and signals from the body about the status of organs and tissues (i.e., afferent projections). These signals can alter the functions of the body, depending on internal and external needs. The BPQ-SF has shown good internal consistency (categorical omega between .77 and .96) and test-retest reliability (r = .96 to .99).
Time Frame
On week two, week 15, week 19, and week 31
Title
Change Interviews (Elliot et al., 2001)
Description
The feasibility and acceptability of video NET will be investigated by conducting Change Interviews with participants approximately one month after completing the treatment. In this instance, the participant will be asked to provide feedback on their experience of receiving treatment, including in terms of barriers and fascinators to engagement. The interviews will be conducted by an external researcher, i.e. another Trainee Clinical Psychologist, following an adaptation of Elliott, Slatick, & Urman's (2001) protocol. The interviews will be audio- or video-recorded and then sent to the student/investigator for transcription and analysis.
Time Frame
At 1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults (18 and over)
Diagnosed with cancer in adulthood
Able to provide informed consent
Able to communicate verbally and speak English
Not in active treatment (at any stage post-treatment)
Suffer from symptoms of traumatic stress caused or triggered by the cancer experience. A diagnosis of PTSD is not required (PTSD Checklist Civilian, PCL-C cut-off score: 29 and above).
No specific form of cancer
Exclusion Criteria:
Participants have a known diagnosis of Intellectual Disability (ID)
Participants must not be receiving other forms of psychosocial support whilst engaging in NET
They are substance dependent
They are actively psychotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Schröder
Organizational Affiliation
The University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG8 1BB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors
We'll reach out to this number within 24 hrs